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The Food and Drug Administration agreed to accept the NDA application for the approval of Celcuity Inc's (NASDAQ:CELC) advanced breast cancer therapy, gedatolisib.
The stock already prices in the prospects, according to HC Wainwright.
The Celcuity Analyst: Analyst Swayampakula Ramakanth downgraded the rating from Buy to Neutral, while raising the price target from $77 to $94.
The Celcuity Thesis: Having risen more than 600% year to date, the stock is "priced for perfection" and there seems to be "more downside risk than upside,” Ramakanth said in the upgrade note.
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The FDA decision on gedatolisib is expected in the third quarter of 2026, the analyst stated. Any delay in approval could cause the market to "turn skittish," he added.
While gedatolisib does hold the potential to change clinical practice, it will compete with large cap pharma companies that have "proven commercial infrastructure in breast cancer," Ramakanth wrote.
The next major catalyst for the stock would be the release of topline data beyond gedatolisib's current indication, which is expected early next year, and a positive result could add 40% to the total addressable market, "while a negative result could initiate a decline in valuation," he further said.
CELC Price Action: Shares of Celcuity had declined by 0.56% to $92.16 at the time of publication on Monday.
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Posted In: CELC
